Validation Engineer

Process validation engineer (interim/freelance)

KEY WORDS: Process validation engineer, Validation engineer, Injection moulding, Operational excellence engineer, lean six sigma, CRA, CRM, Clinical research associate, ISO, GMP, process validation, Biotechnology, Pharmaceutical, Farmaceutisch, Medical Devices, Food Science, Cosmetic, Clinical Research Organisations, HSE, Chemical, R&D, Medical Writing & Communication, Medical Affairs, Regulatory Projects, PhD, Master, Bachelor, Freelance, Interim, zzp, contract, project, temporary, pharma, ISO13485

For a client in the Amsterdam region I am urgently looking for a validation engineer with experience in Injection Moulding.

Location: Randstad region
Contract duration:3 - 6 months + permanent contract possibilities
Budget:Market average
Start date:ASAP

My client is a leading manufacturer of components for Medical Devices. Originally from the U.S., they now have a global reach with plants in Europe, Asia and the U.S. They work closely with leading global pharmaceutical and Medical Devices organisations.

Because of a steady increase in the demand for their services over the past year, they're looking to expand their engineering team with a n experienced validation engineer with experience in preproduction related validation and verification processes.

*Validate pre-production processes and verify processes
*Assure that the product development processes and the correct documentation meet the standards listed in the Design and Development plans
*Draft validation protocols
*Lead risk management sessions
*Discuss validation protocols with clients
*Take part in focus groups regarding Design Assurance
*Train employees on validation standards

The validation engineer must have:

*Experience as a process validation engineer in the Medical Device industry
*Knowledge on GMP, ISO 13485, and ISO 15378, 2859, 3951 and regulatory requirements are a bonus
*Experience with process validation for IM Tool
*Knowledge on plastic materials basics
*BSc. + degree in relevant field
*Basic knowledge on Medical device directive 93/42/EEC, Risk Assessment 14971
*Strong communication skills and fluent in English

Are you interested in this role? Then please send your most up-to-date CV to (see below) and I'll get in touch with you as soon as possible.

Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.